38 results
·
106ms
·
Sources: EU EUDAMED, US FDA
CROSSTREES PVA POD
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
MEDTRONIC XOMED, INC.·00681490034708·PROSTHESIS 1133372 MOD CUP STAPES
N/A
FDA UDI
MEDTRONIC XOMED, INC.·00763000035297·PROSTHESIS 1133372 MOD CUP STAPES
HHM
FDA UDI
Oticon A/S·05707131261038·H100, MINIRITE 312 WL TC HHM
DreamWear Full
FDA UDI
Respironics, Inc.·00606959046337·DreamWear Full Face Mask, Large Cushion, Small ...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613025205·Mayo-Harrington Scissors, Super Cut, Curved, Bl...
NUVANT, MOBILC CARDIAC TELEMETRY
FDA 510(k)
FDA Class 2
·Cardiovascular
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
FDA 510(k)
FDA Class 2
·Neurology
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·March 17, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
UNKNOWN
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 20, 2011
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 13, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 19, 2019
Philips Respironics DreamWear Full Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022
IKAZUCHI ZERO
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 20, 2019
KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·August 21, 2019
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·April 14, 2022
KANEKA PTCA CATHETER CO-R8 (TASUKI)
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·December 13, 2020
KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code LOX·December 21, 2020